EMERGO BY UL SUMMARY OF KEY POINTS:

  • European MDR requirements will increase the need for clinical studies;
  • Proper investigator and investigation site selection is essential for successful studies;
  • PMCF study sponsors and investigators should not underestimate requirements and obligations;
  • In-person facility inspections and personnel interviews should be conducted to mitigate risks and determine proper clinical study support.

With the requirement in the new European Medical Devices Regulation (MDR) to provide an increased amount of clinical evidence, more and more surgeons and physicians will need to be involved, not only in studies conducted to obtain the CE Mark (pre-CE  clinical studies), but also in studies conducted after marketing of the medical  device (post-market clinical follow up or PMCF studies). This is expected to lead, especially in some “popular” indications, to a shortage of surgeons and physicians willing or able to participate in clinical studies.

Pre-CE clinical studies

For pre-CE clinical studies, very stringent requirements apply to the investigators and involved study personnel qualifications, such as certified Good Clinical Practice (GCP) training or documented experience in conducting clinical trials, as well as to the composition of the study team and for the facility and facility equipment. Please note that these requirements can vary to some extent from country to country.

Due to these strict standards the number of investigators who qualify to conduct pre-CE clinical studies is limited. For example, obtaining required GCP training is often a hurdle for otherwise qualified  investigators, as it is often difficult to incorporate these trainings into their busy clinical daily routines.

PMCF studies

For PMCF studies the requirements are less stringent, and generally any surgeon or physician with experience in the field of investigation can become an study investigator. However, whenever possible it is advisable to exclusively include investigators, who are experienced in conducting  clinical studies and ideally also trained in GCP (required in many countries).

Unfortunately, when selecting investigators for PMCF studies the duties and tasks related to the conduct of the study are often underestimated by both the sponsor (device manufacturer) and also the involved investigator. This introduces the risk that the investigator may not be able to include the expected number of patients, or that the quality of the data to be collected suffers.

Selecting investigators and investigational sites

When selecting investigators and investigational sites, a personal site visit is highly recommended even if a good relationship with the potential investigator has already been established for quite some time.

During this visit the planned study should be discussed with the investigator and her/ his interest in participation confirmed. This visit should also be used to assess the site’s infrastructure. A tour through the facilities and discussions with site staff who would be involved in the study should make up a central part of  the program. Experienced clinical research personnel (sponsor personnel or personnel of a Clinical Research Organization or CRO) should be able to identify site-related risks (e.g., lack of study team members, scheduled leave of absence, other foreseeables) and hurdles (e.g., missing or inadequate support by hospital administration).

Conclusion

Investigator and investigation site selection are pivotal for the successful conduct of any clinical study. Unless absolutely impossible, a proper site assessment should be conducted and identified risks should be mitigated. This might even mean that the surgeon or physician intended as an investigator cannot be admitted to participate in the study.

Not appropriately addressing identified risks is very dangerous. For example inclusion of investigational sites which might need additional site support such as additional extensive site trainings or provisions for freelance study personnel will most likely have an impact on timelines and potentially also on data quality. Ultimately this will have an impact on the study costs.

Under no circumstance is it acceptable to attempt to convince physicians or surgeons whose interest in conducting your study is limited or whose capacities are exhausted to participate in your study, as this may lead to problems with a site.

Dietmar Falke is Head of CRO at Emergo Clinical BV.

Related medical device clinical resources from Emergo by UL:

 

AUTHOR

  • Dietmar Falke